The purpose of this study is to document differences between men and women in changes in metabolic variables associated with cardiovascular risk in response to a 4 weeks isocaloric controlled nutritional intervention based on the Mediterranean diet in which all foods and drinks are provided to subjects. The investigators hypothesize that the decrease in LDL-cholesterol will be more important in men than in women.

Nutritional variables [ Time Frame: At baseline (at the beginning of the intervention), at the end of the intervention period (4 weeks) and at 6-months post-intervention (28 weeks). ] [ Designated as safety issue: No ]

Dietary intakes

Eating behaviors [ Time Frame: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks) ] [ Designated as safety issue: No ]

Restraint, disinhibition, and susceptibility to hunger

Appetite ratings [ Time Frame: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks) ] [ Designated as safety issue: No ]

Desire to eat, hunger, fullness, and prospective food consumption

physical activity habits [ Time Frame: At baseline (at the beginning of the intervention) and at the end of the intervention period (4 weeks) ] [ Designated as safety issue: No ]

Anthropometric measurements [ Time Frame: At baseline (at the beginning of the intervention), at the end of the intervention period (4 weeks) and at 6-months post-intervention (28 weeks) ] [ Designated as safety issue: No ]

Men who are assigned to a 4 weeks experimental diet formulated to be concordant with characteristics of the traditional Mediterranean diet.

Other: Controlled nutritional intervention based on the Mediterranean diet

Men are assigned to a 4 weeks isocaloric controlled nutritional intervention based on the Mediterranean diet (MedDiet) in which all foods and drinks are provided. The respective percentages of kcal derived from lipids, carbohydrates, protein and alcohol are respectively of 32%, 48%, 15% and 5%. Habitual energy intake of each participant is established by averaging energy requirements estimated by a validated food-frequency questionnaire (FFQ) and energy needs as determined by the Harris-Benedict formula. Body weight is measured on weekdays and total energy provided is revised if necessary for minimizing body weight fluctuations. This intervention period is preceded by a 4 weeks uncontrolled run-in period based on the Canada's Food Guide.

Experimental: Women and Mediterranean diet

Women who are assigned to a 4 weeks experimental diet formulated to be concordant with characteristics of the traditional Mediterranean diet.

Other: Controlled nutritional intervention based on the Mediterranean diet

Women are assigned to the same intervention than men in order to compare men and women metabolic response to the MedDiet.

Detailed Description:

Nutritional interventions promoting the adoption of the traditional Mediterranean diet (MedDiet) are known to have significant and beneficial effects on cardiovascular disease (CVD) risk profile. On the other hand, recent evidence suggests that women respond differently to diet than men. No study has yet compared men and women metabolic response to the MedDiet in a controlled metabolic context in which all foods and drinks consumed are provided to the participant prepared by the research team. Therefore, we do not know whether being fed a MedDiet in controlled conditions would have similar health benefits in men and women. The purpose of this study is to document differences between men and women in changes in metabolic variables associated with cardiovascular risk in response to a 4 weeks isocaloric controlled nutritional intervention based on the MedDiet in which all foods and drinks are provided to subjects. We hypothesize that the decrease in LDL-cholesterol will be more important in men than in women. In this parallel controlled trial, both men and women are assigned to the same 4 weeks experimental diet formulated to be concordant with characteristics of the traditional MedDiet. Data will be collected before and after the controlled nutritional intervention based on the MedDiet.

Subjects with food allergies or food aversion that could impede compliance to the Mediterranean diet

Pregnant women and those using systemic hormonal contraceptives

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01293344

Locations

Canada

Institute of Nutraceuticals and Functional Foods (INAF), Laval University

Quebec, Canada, G1V0A6

Sponsors and Collaborators

Laval University

Canadian Institutes of Health Research (CIHR)

Heart and Stroke Foundation of Canada

Investigators

Principal Investigator:

Simone Lemieux, Ph.D., Dt.P.

Department of food sciences and nutrition / Institute of Nutraceutical and Functional Foods (INAF), Laval University